Rapid H. pylori detection with PYLORITOP® Ag Rapid H. pylori detection with PYLORITOP® Ag

Posted on March 2, 2012 by Maysun Butros

Pro-Lab Diagnostics has released a rapid visual assay for the detection of H. pylori in faecal samples. PYLORITOP® Ag+ is an immunochromatogenic test designed to provide clinical laboratories with a cost-effective assay to help meet current guidelines for the detection and treatment of H. pylori 1.

Infection with H. pylori is estimated to affect 40 ­ 50 % of the population, and can have a significant impact on the treatment of patients with gastroduodenal diseases, gastric cancers and unexplained iron deficiency anaemia. PYLORITOP® Ag+ provides a quick and convenient non-invasive test for H. pylori infection, offering rapid qualitative results in just five minutes to help guide clinical pathways and avoid unnecessary treatments. Based on robust lateral flow technology, individually wrapped PYLORITOP® Ag+ test cassettes are supplied with a sample collection tube for maximum convenience, and can be safely stored at room temperature for up to 12 months, providing a practical solution for H. pylori testing.

Mark Reed, General Manager of Pro-Lab Diagnostics, commented: ³PYLORITOP® Ag+ is the latest addition to Pro-Lab Diagnostics¹ portfolio of immunodiagnostic products, and is supported by our knowledgeable and friendly team of experts. This simple test offers clear, qualitative results in just a few minutes, helping to streamline laboratory workflows for better patient care.²

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OGT Signs Licensing Deal for Colorectal Cancer Biomarkers

Posted on March 1, 2012 by Maysun Butros

Oxford Gene Technology (OGT), provider of innovative clinical genetics and diagnostic solutions to advance molecular medicine, announced today that it has entered into an exclusive licensing agreement with Inven2, the technology transfer office at Oslo University Hospital (OUS) and University of Oslo (UiO), for 12 highly promising colorectal cancer tissue biomarkers.

The exclusive license allows OGT to commercialise any resulting test developed using these biomarkers and to sublicense the markers to other parties. The DNA methylation biomarkers were developed in the laboratory of Professor Ragnhild A. Lothe, in the department of Cancer Prevention, the Norwegian Radium Hospital, part of the Oslo University Hospital.

OGT has validated the results obtained in Professor Lothe’s laboratory showing sensitivity of 93% and specificity of 90% when using tissue biopsies. Further work investigating the efficacy of these biomarkers in blood and faecal samples is ongoing.

“This licensing agreement gives OGT exclusive access to genetic markers which are associated with colorectal cancer.” stated Mike Evans, CEO, of OGT. “We believe that developing tests that include these genetic markers will permit the earlier identification of patients at risk of this disease and allow for more timely diagnosis and clinical interventions.” He added, “The higher specificity of this new panel of markers could provide a more robust screening tool than the tests currently used, while eventually lowering overall costs, which would be of significant benefit for both patients and the clinicians using them.”

“Biomarkers have the potential to greatly improve the accuracy and impact of colorectal cancer screening.” commented Professor Lothe, from the Norwegian Radium Hospital. “We look forward to continuing our collaborative efforts with OGT to develop and validate a future test which will help screen people early for this treatable form of cancer.”

Benedicte Bakke, Business Development Manager at Inven2 AS, Oslo technology transfer office, concluded: “We fully support the collaboration with Oxford Gene Technology to develop a new method of detecting colorectal cancer using these biomarkers. This deal demonstrates the importance of industry and academic collaboration in turning scientific excellence into products that address medical needs.”

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NUFFIELD HEALTH PATIENTS CAN NOW BENEFIT FROM INDIVIDUA Treatment Planning For Early Stage Breast Cancer

Posted on March 1, 2012 by Maysun Butros

Increased access to Genomic Health’s Oncotype DX test helps predict risk of recurrence and chemotherapy benefit, sparing women in the UK from unnecessary chemotherapy treatment

Patients at Nuffield Hospitals now have access to the Oncotype DX® Breast Cancer Test ­ a unique genomic test that enables clinicians and their patients with early stage breast cancer to make more informed, individualised treatment decisions. Breast cancer is the most commonly diagnosed cancer in women, and almost 50,000 people are diagnosed with breast cancer each year in the UK.

Oncotype DX is the first genomic test that helps inform each woman with breast cancer about both her own personal risk of breast cancer recurrence and the likely benefit from chemotherapy. In the ideal world, cancer specialists would like to offer each patient a risk assessment and treatment plan that is specific for that individual. The use of this test in the planning of individualised cancer care can help patients and their doctors make treatment decisions with the best possible information, said Mr. Charlie Chan FRCS, Consultant Surgeon at Nuffield Health Cheltenham Hospital and Cheltenham General Hospital. This will allow chemotherapy to be used where it will be most beneficial to women and spare some women from having chemotherapy, when it is not needed. Ultimately this will lead to significantly reduced financial costs and importantly improved wellbeing for many patients. The Oncotype DX Recurrence Score is a major advance and will help many women both now and in the future.

Oncotype DX is the only test that has significant clinical evidence validating its ability to predict the likelihood of adjuvant chemotherapy benefit as well as recurrence in early-stage breast cancer. Furthermore, no other breast cancer test has demonstrated the reproducible clinical utility that Genomic Health has established with Oncotype DX, including 13 clinical studies involving more than 4,000 breast cancer patients worldwide. Oncotype DX is widely recognised and is included in multiple international guidelines:  in Europe it is included in the European Society for Medical Oncology (ESMO) and St. Gallen International Breast Cancer Expert Panel guidelines as a predictor of chemotherapy benefit.

The collaboration with Nuffield is exciting. Oncotype DX is increasingly becoming incorporated into clinical care in the UK and the rest of Europe, and it was recently approved for use in the public health system in Ireland.  We feel it is important for women with early breast cancer to have access to a test that can make them feel more confident about their treatment decision. Working together with Nuffield we hope that more women will be able to benefit from the test, said Dr. Andrea Pithers, MRCGP, UK Lead for Genomic Health.

Adding to the growing body of evidence reconfirming Oncotype DX’s clinical utility and cost effectiveness, the latest study results presented at the 2011 San Antonio Breast Cancer Symposium (SABCS) show that 46 percent of the UK patients who were initially offered chemotherapy and hormone therapy were spared chemotherapy after review of the Oncotype DX Recurrence Score® (RS).  Furthermore, overall physician treatment recommendations were changed by approximately 27 percent following knowledge of the RS.  A second study, examining the cost effectiveness of Oncotype DX, showed a 99.6 percent probability that the test would be cost-effective in the United Kingdom, versus current clinical practice.

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New Treatment for Liver Cancer Patients

Posted on March 1, 2012 by Maysun Butros

BMI The Alexandra Hospital is the first hospital in the North West to provide a new, non-surgical treatment for liver cancer. The DEBIRI (Drug-Eluting Beads delivering Irinotecan) treatment is for patients suffering from both primary, where the disease originated in the liver or secondary liver cancer – where it travelled to the liver from another organ such as the bowel or breast.The DEBIRI treatment is minimally invasive and treats patients who have inoperable tumours by shrinking them and making surgery possible.

The procedure involves inserting a catheter ­ a thin plastic tube – into an artery which supplies blood to the tumour.  The tumour is then injected with fluid containing microscopic chemotherapy beads, which directly attack the cancer.

At the same time, the beads obstruct the tumour¹s blood supply, depriving it of oxygen and nutrients which prohibit its growth.  By injecting chemotherapy directly into the liver, many of the side effects can be decreased or avoided.

The DEBIRI treatment is carried out by a multi-disciplinary team at BMI The Alexandra Hospital, lead by Consultant Medical Oncologist Dr Greg Wilson, and Consultant Interventional Radiologist Dr Finn Farquharson.

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iCyt Unveils Exciting New Flow Cytometry Reagents Utilizing Innovative Fluorochrome Technology

Posted on April 27, 2011 by Maysun Butros

A new line of 405nm-excited fluorochrome conjugated antibodies for flow cytometry

iCyt Mission Technology, Inc. (iCyt), a wholly-owned subsidiary of Sony Corporation of America, has announced the introduction of its new line of 405nm-excited fluorochrome conjugated antibodies for flow cytometry. These new Brilliant Violet™ 421 products are part of the first commercial release of a novel, polymer-based fluorophore technology.

“This exciting new class of fluorescent probes will make significant contributions to the future of flow cytometry, by bringing new power and utility to the violet (405nm) laser,” said Gary Durack, CEO of iCyt. “The new Brilliant Violet fluors offer dramatic improvements in brightness and signal-to-noise ratio over the current choices for the violet laser.”  

In addition to being an order of magnitude brighter than traditional violet excited fluorochromes, this new dye offers greater sensitivity for resolving weakly expressed antigens, and requires less compensation for spectral overlap. Their compatibility with other popular fluorochromes and fluorescent protein combinations offers versatility that will further expand researchers’ options for multi-color panels.

The initial iCyt portfolio of anti-mouse and anti-human conjugates have been optimized for use with iCyt’s Eclipse™ analyzer and upcoming Synergy™ benchtop sorter, but are compatible with all major commercial flow cytometers equipped with a 405nm laser.

The new BV421 line will include an extensive antibody selection that combines consistent bright staining that is effective for surface and intracellular antigens, with simple, ready-to-use, low volume test size.  The new probes are fixation stable and compatible with standard staining buffers.  

iCyt intends to continually expand its new line of BV reagents, which complement its already broad portfolio of mouse and human monoclonal antibodies tailored for use in cell biology, immunology, cancer research, and stem cell research.

“iCyt and Sony are committed to leading the way in bringing innovative, new instrument and reagent technology combinations to market, that maximize performance and value for our customers,” added Durack.

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Brainlab Harnesses the Cloud with Quentry™

Posted on April 26, 2011 by Maysun Butros

Global Medical Network Offers Secure Data Sharing and Collaboration

Key Development Neurosurgeons Queue Up to Enroll at Launch

Brainlab today goes live with Quentry™, a groundbreaking online network for physicians that provides the freedom to access, control and share diagnostic imaging from anywhere within a secure clinical platform. Debuting at the AANS Annual Scientific Meeting in Denver, Colo., clinicians can employ the now consumerized online sharing mentality to disseminate expert knowledge and enhance patient care. For a limited time, neurosurgeons may sign up for Quentry and take advantage of a free trial phase offering a unique opportunity to explore the site.

“Giving clinicians the freedom to exchange and discuss patient cases, share insights and moderate best practices with peers the world over helps drive the right care for the right patient at the right time,” said Stefan Vilsmeier, CEO and founder of Brainlab. “Social networking has transformed how people communicate; Quentry will transform how clinicians practice medicine.”

Quentry connects users via cloud computing technology, which enables access from any fixed connection within a secure network without having to download special or specific software. Functionality includes secure uploading, sharing, viewing and consulting with clinical members around the world. Providing applications from centralized servers and operating in highly secure and robust datacenters, Quentry eliminates time-consuming and costly CD production and increases security by eliminating misplacement of medical data CDs.

“This new clinician networking initiative aligns perfectly with the Brainlab strategy,” explains Stefan Henning, product line manager for Quentry. “We are forging ‘A Quentry without borders,’ for both Brainlab and non-Brainlab clinicians who will benefit enormously from this innovative worldwide network based on freedom, accessibility and unification of clinical knowledge.”

Bringing the company’s advanced technologies into the cloud, Quentry is the only PACS-independent online network for moderating clinical best practices combined with the ability to share and discuss medical images with an advanced web-based DICOM viewer. Members can freely upload and access diagnostic patient images, harness powerful on-demand tools to visualize data, consult colleagues and synchronize work. The network capability allows surgeons to invite colleagues to join their network, consult on a case and moderate best practices, all with the goal of providing the best care possible.

Quentry can connect all the people in the care path – patient, referring physician and specialist – with the goal of streamlining the planning and treatment process and decreasing patient travel where possible. The online transfer of data sets via Quentry means that treatment plans can be prepared before the patient arrives at the hospital and that referring physicians can be directly involved in the treatment. Post-treatment follow-up between clinical specialists is streamlined and the patient reaps the benefits of the interconnectivity offered by Quentry.

Significant upgrades in the coming months will connect Quentry with all Brainlab devices and applications such as iPlan® treatment planning software and will make it an accessible archive of clinical data. Soon, Quentry will offer direct web access to its intelligent software and computational power allowing clinicians to filter, enrich, visualize and leverage digital data.

Quentry services are scalable, ranging from free user login to a full-featured premium subscription version. The site ensures compliance with HIPAA privacy and security rules, safeguarding patient confidentiality.

To learn more and sign up, visit booth 2241 at AANS or www.quentry.com.

About Brainlab

Brainlab develops, manufactures and markets software-driven medical technology that supports targeted, less-invasive treatment. Core products are image-guided systems and software that provide real-time information used for surgical navigation and radiosurgical planning and delivery.

Brainlab technology drives collaboration between hospitals and clinicians from a wide variety of subspecialties—from neurosurgery and oncology to orthopedics, ENT, CMF and spine & trauma. This integration delivers better access to improved and more efficient treatment.

Founded in 1989, the privately held Brainlab group has 5,260 systems installed in over 80 countries. Based in Munich, Germany, Brainlab employs 950 people in 16 offices worldwide. To learn more, visit www.brainlab.com.

™ Quentry is a trademark of Brainlab AG, registration pending.

® Registered trademark of Brainlab in Germany and/or US.

SOURCE Brainlab

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Brainlab and SurgiVision Announce Strategic Alliance in MRI-Guided Drug Delivery and Other Interventional MRI Technologies in Neurosurgery

Posted on April 25, 2011 by Maysun Butros

Brainlab AG and SurgiVision, Inc. has announced a collaboration aimed at integrating SurgiVision’s ClearPoint® product line with Brainlab’s iMRI product line

With particular focus on local delivery of drugs and other therapeutic agents to precision targets in the brain under magnetic resonance imaging (MRI) guidance,Brainlab and SurgiVision believe the integration of their technologies will allow patient-specific treatment planning, simplified clinical workflows and optimal delivery of drugs to the brain.

Under the terms of the agreement, Brainlab also received the right to sell SurgiVision’s ClearPoint product line, including the right to exclusively sell ClearPoint products in the neurological drug delivery field, and Brainlab made an investment into SurgiVision.  SurgiVision will continue to sell its ClearPoint product line directly for all applications outside the neurological drug delivery field.

SurgiVision’s ClearPoint system provides guidance for the placement and operation of instruments during neurological procedures performed within the MRI environment.  Using the ClearPoint system, a physician sees and selects a neurological target, aims SurgiVision’s targeting device and watches via MRI as the surgical instrument is advanced to the target and the therapy is delivered.  SurgiVision’s ClearPoint system has received both FDA clearance and CE Mark.  SurgiVision also recently received FDA clearance for its SmartFlow™ injection cannula.

Brainlab’s Brainsuite® iMRI integrates intra-operative MRI with surgical planning and ceiling-mounted navigation, allowing full utilization of intra-operative data for making informed decisions  during the procedure.  iPlan® Flow enables neurosurgeons to optimize local drug delivery to the CNS, based on patient specific imaging.

“Direct, image-guided delivery of therapeutic agents into the brain provides the next generation platform for delivering a wide range of promising therapies for patients suffering from CNS disorders such as Parkinson’s disease and malignant brain tumors,” said Dr. Krystof Bankiewicz, Vice Chair and Professor, Department of Neurosurgery and Director of the NeuroTherapeutics Delivery Center at the University of California San Francisco.  ”This collaboration between two important players in the field is welcome news to pharmaceutical companies, biotech companies and researchers with therapeutic agents that need to be delivered in a targeted, patient-specific, image-guided fashion.”

“MRI guided interventions is an important, emerging area of medicine.  We are excited about the partnership with SurgiVision, the integration of our technologies in functional neurosurgery, and the opportunity to offer these innovative solutions to customers through our global sales network,” said Stefan Vilsmeier, CEO of Brainlab.

“We are very pleased to announce this collaboration with Brainlab, a pioneer and leader in image-guided interventions,” said Kimble Jenkins, CEO of SurgiVision.  ”Together with our new partner, we are excited about providing to clinicians powerful, new capabilities in targeted drug delivery and other MRI-guided therapies to benefit patients who suffer from CNS disorders.”

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Magellan Biosciences and Miacom Diagnostics Team Up to Enable Faster, Easier Identification of Pathogens

Posted on April 24, 2011 by Maysun Butros

As Part of Magellan’s End-to-End Suite of Microbiology Products, this is Designed to Streamline Lab Workflow and Enable Better Treatment Decisions

Suitable for microbiology labs of all sizes, miacom’s family of 30-minute molecular tests identify sepsis-related pathogens directly from blood-culture bottles

Magellan Biosciences, a global manufacturer of products designed to make diagnostic testing easier, more cost-effective, and less labor-intensive, is partnering with Germany-based miacom diagnostics GmbH to bring miacom’s unique, cost-effective family of molecular tests to the U.S. and Canadian markets. The 30-minute tests identify sepsis-related pathogens directly from blood-culture bottles, enhancing Magellan’s suite of blood culture, microbial identification, and susceptibility test products for microbiology laboratories. The combined offering is designed to provide fast, reliable results for laboratories of all sizes, enabling clinicians to make more-informed treatment decisions that improve patient care and help in the global fight against drug resistance.

The product suite will include Magellan’s TREK-brand VersaTREK microbial-detection system, miacom’s lucesco® IVD (in vitro diagnostic) kits for affordable, rapid identification of bacteria and fungi/yeast from blood cultures, and Magellan’s TREK-brand Sensititre® susceptibility-testing system. Pathogens from a positive blood culture on the VersaTREK system can be identified quickly using a lucesco IVD kit, with microbial susceptibility determined using the Sensititre system. Under the terms of the agreement, Magellan will be the exclusive U.S. and Canada provider of Bacteremia and Fungimia panels using the miacom platform. Four miacom diagnostics tests have already been approved for use in Europe; this year, Magellan expects to market a family of miacom sepsis tests available for research use only in the U.S. while beginning the clinical trials toward FDA clearance.

Commenting on the agreement, miacom’s Chief Executive Officer, Mirko Stange, Ph.D., said, “We are pleased to partner with Magellan to improve patient care across the globe. Unlike most other molecular technologies, miacom assays can be performed in virtually any microbiology laboratory. Doctors no longer have to rely on an empirical approach to therapy – the combination of our rapid lucesco IVD results and Sensititre susceptibility testing eliminates guess work, enabling clinicians to prescribe the best, most-targeted therapy to their patients as quickly as possible.”

The miacom assays, which incorporate a next-generation fluorescence in situ hybridization, streamline and greatly simplify molecular testing – yielding multiplex pathogen identification in just 30 minutes. Further, handling and performance limitations from error-prone washing steps common to traditional techniques are completely eliminated in miacom’s proprietary method. The workflow is as simple as performing a Gram stain and results are available one- to five-days earlier than traditional culture methods.

“Getting patients on the correct antibiotic, in the right dosage, in the least amount of time is crucial to both patient health, and to countering the emerging problem of drug resistance,” said Magellan President and Chief Executive Officer Hiroshi Uchida, Ph.D. “By combining rapid miacom identification technology with the flexibility and accuracy of the VersaTREK and Sensititre systems, laboratories of all sizes can battle drug resistance with a cost-effective solution for blood culture, identification, and susceptibility testing.”

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Point-of-Sale Electronic Safety Check May Reduce Heart Attack Risk for Diabetic Patients

Posted on April 23, 2011 by Maysun Butros

Program Flags Insulin or Nitrate Use for Patients Filling Avandia Prescriptions

According to a new pharmacy benefit study, a point-of-sale automated electronic safety edit, designed to require provider prior authorization (PA) for members who have a rosiglitazone claim with concurrent use of insulin or nitrate (CIN), potentially decreased members’ risk for myocardial ischemia. The study will be presented at the Academy of Managed Care Pharmacy’s 23rd Annual Meeting in Minneapolis, Minn. by Prime Therapeutics (Prime), a thought leader in pharmacy benefit management.

Rosiglitazone, also known under its brand name Avandia®, is an antidiabetic drug therapy (ADT) designed to help control blood sugar in patients with Type 2 diabetes mellitus. Studies suggest rosiglitazone and CIN can put patients at an increased risk for myocardial ischemia, a condition where the arteries in the heart become blocked, thus increasing a person’s risk for heart attack.

To prevent use of rosiglitazone and CIN, one of Prime’s Blue Cross and Blue Shield (BCBS) clients implemented an automated electronic safety edit that included 1.2 million members. The edit required a PA for rosiglitazone if a CIN drug supply already existed.

During the six-month study period (Jan-Jun 2009), 168 members had their rosiglitazone claim denied at the point-of-sale. Researchers conducted an observational cohort study to assess ADT utilization in the 168 members in which a rosiglitazone claim was denied. Researchers also assessed a control group of 222 members for whom the safety edit was inactive. Claims for both groups were periodically observed post-denial, or post-initial paid rosiglitazone claim among control group, to determine whether members continued with rosiglitazone, switched to a safer alternative or abandoned therapy altogether.

After 180 days, 78.6 percent of the 168 members with an initial safety edit claim denial were using a different ADT other than rosiglitazone, versus only 25.6 percent of control group. The safety edit did not result in increased ADT abandonment. Only 13 percent of affected members abandoned an ADT drug altogether, compared with 15 percent in the control group.

“This study shows insurers can successfully implement safeguards to protect members from potentially harmful drug interactions,” said Patrick Gleason, PharmD, Prime’s Director of Clinical Outcomes Assessment. “Through the use of this safety edit, many patients were able to avoid potential heart complications that would require further medical treatment and unnecessary medical costs.”

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Lanx®, Inc. Announces Launch of Concero™ Facet Screw System for Spinal Fusion

Posted on April 22, 2011 by Maysun Butros

The Concero system is a minimally invasive fixation alternative to pedicle screws, intended to stabilize the spine during fusion procedures at single or multiple levels from L1 to S1 through bilateral immobilization of the facet joints.

Lanx®, Inc., a privately held medical device company focused on developing and commercializing innovative devices for spinal surgery, has announced the launch of the Concero™ Facet Screw System (Concero) at the 2011 American Association of Neurological Surgeons (AANS) Annual Meeting, Denver, CO.

The Concero system is a minimally invasive fixation alternative to pedicle screws, intended to stabilize the spine during fusion procedures at single or multiple levels from L1 to S1 through bilateral immobilization of the facet joints. It is available in multiple lengths and diameters and in both cannulated and non-cannulated versions with customized instrumentation. The system also features a toothed washer for improved bone fixation and a lag screw design for secure compression, eliminating the need for external compression mechanisms.

“The new Concero facet screw is an important enhancement to the Lanx fusion product suite and has been receiving positive feedback from surgeons,” said Dan Gladney, Chief Executive Officer, Lanx. “The customizable system lends itself to many minimally invasive applications, both as stand-alone fixation and as part of larger fixation constructs, reinforcing our commitment to developing simple, intuitive implants and instrumentation that increase options for surgeons and improve care for their patients.”

The Concero system can be used in combination with other fixation devices in surgical cases in need of additional motion restriction. Recent biomechanical testing shows the Lanx Aspen™ Spinous Process Fixation System coupled with Concero facet screws demonstrates overall stability and range-of-motion comparable to the Aspen device coupled with pedicle screws, and the Concero system construct may be a less invasive fixation method.(1)

“Concero facet screws are intuitive and straightforward to implant, with simple instrumentation that was designed with the needs of the surgeon in mind,” said Glenn L. Keiper, M.D., neurosurgeon at Spine & Brain Center of Eugene, OR. “The system provides secure, reliable fixation and compression and is an effective alternative to pedicle screws, both in stand-alone or combined fixation procedures, and especially in the lower spine where the facet joints are more defined.”

The Concero system is commercially available to surgeons in the U.S. and is one of several innovative products that will be on display at the Lanx AANS booth #1016. For more information about the Concero system or Lanx, please visit www.lanx.com.

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